In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)
NCT ID: NCT01002651
Last Updated: 2009-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2009-03-31
2009-10-31
Brief Summary
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The objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Wheat Bran Extract (high dose)
wheat bran extract
soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner
Wheat Bran Extract (low dose)
wheat bran extract
soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner
placebo
placebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner
Interventions
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wheat bran extract
soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner
placebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular eating habits
* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Consent to take in the study product according to the study protocol
* Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
* For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception
Exclusion Criteria
* Recent use of antibiotics
* Abdominal surgery in the past
* Serious illness within 3 months of start of clinical trial
* Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication
* Complete anesthetics within 1 month of the start of the clinical trial
* Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
* Allergy for wheat products
* Celiac disease
* For female volunteers: pregnant or lactating
* Alcohol abuse
* Smoking more than 5 cigarettes per day
* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.
18 Years
90 Years
ALL
Yes
Sponsors
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Fugeia NV
INDUSTRY
Responsible Party
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Katholieke Universiteit Leuven
Principal Investigators
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Willem Broekaert, Ph.D.
Role: STUDY_DIRECTOR
Fugeia NV
Locations
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Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, , Belgium
Countries
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Other Identifiers
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ML5282
Identifier Type: -
Identifier Source: org_study_id
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